The Senior Manager, Regulatory Affairs, Growth Markets will work closely with regulatory colleagues at affiliates/business partners to support the development and implementation of regulatory strategies to allow timely submissions, approvals, and optimal labels, by working closely with all relevant stakeholders within The company.
This position contributes to the planning, execution and assessment of product life cycle management activities and strategies. In addition, this person will also be encouraged to continuously expanding his/her knowledge in Growth Markets regulatory environment and local requirements, acting as a point of contact between the affiliate/partner and the global functions within The company to create high-quality dossiers to enable an efficient and effective registration process aligned with the commercial objectives of the company.
Contributes to the development and implementation of regulatory strategies for the assigned projects. Lead issue resolution of regulatory risks by identifying, escalating and monitoring issues.
Organize resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.
Contribute to the planning, execution, and assessment of product life cycle management activities and strategies.
Assists, as needed, interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities, and may participate in phone or in-person meetings.
Contribute to the department-wide work-stream/initiatives, as assigned.
BS/BA in Life Sciences in a relevant field with minimum 5 years of broad pharmaceutical industry experience, including 3 years of experience with new/innovative drug registration strategy/submissions, or
MS with 4 years of broad pharmaceutical experience including 2+ years of experience with new/innovative drug registration strategy/submissions.
An advanced degree (PharmD or PhD) preferred
Previous regulatory experience in Emerging/Growth Markets (international) region, preferred
Experience of the Drug Development process and working with international/global project teams
Working knowledge of relevant drug laws, regulations and guidance's/guidelines
Desirable to have previous experience in therapeutic area
Ability to assume accountability for a project goal/objective
Experience in leading team discussion to resolve and reach agreement on project issues.
Excellent written and oral communication skills